I. Field of the Invention
This invention relates generally to a system for treating female stress incontinence, and more particularly to a kit containing components for facilitating placement of an incontinence prevention device in the female urethra.
II. Discussion of the Prior Art
In my U.S. Pat. No. 6,311,689B1, I describe an incontinence prevention device that comprises a soft, flexible, elastomeric shaft member, preferably silicone, that is sized to fit in the female urethra and which has a retention structure in the form of a closed loop at a distal end of the shaft member that is adapted to cooperate with the bladder neck to prevent the device from being expelled during voluntary urination. The device further includes a proximal wing-like retention structure adapted to cooperate with the vestibule proximate the urethral meatus to prevent upward migration.
In order to insert the incontinence prevention device, a lumen is provided for receiving a straightening stylet therein. With the stylet fully inserted, the distal retention loop is rendered generally rectilinear so as to exhibit a low profile. The tip portion may then be lubricated and the device is inserted by advancing the distal retention structure in its straightened condition on the stylet through the urethral meatus and up the urethra until the distal retention device is resident in the patient""s bladder. At this point, the stylet is removed, allowing the loop to reform on the distal end of the shaft.
While the device and method of insertion described in the ""689 patent is safe and effective, concern has been expressed by some patients about the use of a stiffening stylet. Some have expressed fear that the stiffening stylet might be made to pierce through the wall defining the stylet lumen, and that it could result in injury to the urethral wall as the incontinence prevention device is being inserted.
It is accordingly a principal object of the present invention to provide a method and apparatus for inserting an incontinence prevention device in the female urethra that does not require the use of a stiffening stylet wire to render the device initially rectilinear for placement within the urethra.
It is a further object of the invention to provide an incontinence prevention device and an insertion mechanism as a kit for use by a patient at home and without the aid of a medical professional.
The present invention provides a kit for use in treating female stress incontinence. The kit contains an incontinence prevention device having a relatively soft, elastomeric shaft with a closed loop bladder retention structure at a distal end thereof and a vestibule engaging retention structure at its proximal end. The insertion assembly includes a deployment base member having a finger grip at a proximal end thereof and at least one rigid shaft projecting longitudinally from the finger grip. The rigid shaft includes a device engagement element at its distal end. The kit further includes a tubular handle, referred to herein as a deployment tube, for receiving the incontinence prevention device in a lumen thereof at a time immediately prior to deployment of the incontinence prevention device into the urethra. The deployment tube is slidable over the rigid shaft for facilitating loading of the incontinence device into the lumen of the deployment tube. Its diameter is such that the retention loop is collapsed and rectilinear. The kit further contains a plunger that is adapted to fit within the lumen of the deployment tube and which can be used to eject the incontinence device from the deployment tube into the urethra.
The incontinence device can be loaded into the deployment tube a short time prior to self-placement into the urethra so that the retention loop does not take a set, that could preclude the loop retention structure from opening up upon reaching its location in the bladder neck. Moreover, there is no need for the patient to touch the incontinence device itself, thereby maintaining a sterile condition and minimizing the occurrence of infection.
There are, of course, additional features of the invention that will be described hereinafter which will form the subject matter of the appended claims. Those skilled in the art will appreciate that the preferred embodiments may readily be used as a basis for designing other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions since they do not depart from the spirit and scope of the present invention. The foregoing and other features and other advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.